1. Field of Invention
The present application generally relates to nutrition, in particular an ultra-high fiber supplement, the making of the supplement, and its use in weight loss, promoting health, and minimizing disease.
2. Discussion of the Prior Art
Many medical conditions are partially or fully related to the diet consumed. Individuals living in industrialized countries suffer from a diet that is too high in fats, cholesterol, salt, and sugars, and grossly deficient in complex carbohydrates and fiber. Most foods consumed are highly refined and stripped of fiber and nutrients. To make them appealing and commercially successful these foods are then enhanced with fat and sugars. Such foods are a multi-billion dollar industry, which is rapidly growing. Snack foods are notorious for being rich in salt, fat, cholesterol, and calories. The explosion in snack foods available over the past 15 years closely mirrors the increased incidence of obesity that has become alarmingly prevalent. The National Cancer Institute estimates that at least 30% of cancers are diet related. The explosion of diabetes is related to a diet too rich in calories and simple sugars. Coronary artery disease accounts for 50% of deaths and is strongly related to cholesterol, saturated fats, and obesity. Another common disease tied to obesity is sleep apnea, a breathing disorder that occurs while sleeping, is responsible for cognitive dysfunction, a variety of medical ailments and even death.
Even so called low-fat or “light” snacks have their problems. Many “light” snacks are not really low in fat but meet the criteria to be called “light” or low fat because they contain one-third fewer calories or half the fat of a non-light or reference food. Hence, a food item that may contain 20 grams of fat is considered “light” if the reference food contained 40 grams of fat. Low-fat foods by definition can contain up to three grams of fat per serving. The public is further harmed by the fact that serving sizes are not standard and confusing. A low-fat cookie containing 3 grams of fat becomes a substantial source of fat when two or more are consumed. Unfortunately many of these seemingly healthy products are not healthy since they contain hydrogenated fats, cholesterol, saturated fats, and trans fats—all considered harmful. The beverages consumed by both children and adults have contributed to the obesity of the population. Most of these drinks are high in sugar (sucrose or high-fructose corn syrup).
The public is inundated by ads claiming to offer health benefits for various products. In reality, many of these products offer little or no help and may even be detrimental to health. Many health fads have come and gone. The Federal Drug Administration has little control over the exploding nutritional supplement market that permits companies to make unsubstantiated claims, and launch new products that have no proven value. The growing market for nutritional supplements and the lack of tight state or federal regulation serves only to confuse the consumer.
Obesity is rising at epidemic proportions for both children and adults. Marketers seeking to profit from this market have introduced a variety of weight-loss products that are ineffective. These include so-called fat blockers, starch blockers, magnetic diet pills, diet patches, spirulina (blue-green algae), weight-loss earrings, appetite-suppressing eyeglasses, a variety of herbal products, electrical stimulators, etc.
Many diet products on the market are outright dangerous. Thermogenic products—touted to speed metabolism—contain actual stimulants that can be harmful or deadly. Many diet products contain such stimulants as ephedra, ma huang, and kola nut; these are names the public does not readily equate with stimulants. Over-the-counter diet pills, while being commercially successful, have not produced sustained weight loss. Most doctors consider these products to be ineffective and potentially dangerous.
Prescription medications for weight loss have had limited success as well. People have taken prescription stimulants and thyroid medications. These can only be used temporarily and have numerous side effects (hypertension, insomnia, palpitations, dizziness etc.). A new product, sold under the trademark XENICAL (orlistat) by, Hoffmann-La Roche Inc. Nutley, N.J., attempts to minimize fat absorption in the gut. It has not turned out to be the panacea we had hoped for. It must be consumed three times per day and has side effects of diarrhea, abdominal pain, fecal incontinence, and vomiting. It can also cause a deficiency in fat-soluble vitamins. Despite taking this medication three times daily for a year, and partaking in a reduced-calorie diet, the weight loss in a test group was on average only 13.4 lbs at the end of one year—just greater than a pound per month.
Various commercial weight-loss centers exist. They use various methods to help weight reduction. Some offer prepackaged meals that reduce choice, and can be costly. Others are overly cumbersome, requiring food items to be weighed or converted into a number of calories or points that are then restricted on a daily basis. Some of these programs have group counseling which may be inconvenient or embarrassing.
Several weight-loss drinks are commercially available. Typically, they consist of low-calorie meal replacements. Some are premixed and ready to drink. Some are dry powder mixes that are reconstituted in liquid to form a sweet-tasting, fruit-flavored liquid. These drinks have allowed some to lose weight, but they have had little success in getting most people to reduce their weight down to the ideal body weight and maintain it. Furthermore, most users abandon the program and regain their weight.
There are several problems with these drinks. In order to make the drink taste good they have added fat, salt, sugar, and even undesirable sweeteners. Many of these meal replacement drinks do not taste well, are not satiating, and commonly people become bored with drinking the same flavor or group of flavors daily. Eventually, the person drops the drink program and gains their weight back.
Some of the drinks do not contain any fiber. Typically the drinks contain 3 grams of fiber or less. Many of contain undesirable ingredients, such as fat, saturated fat, and sugars. These fats and sugars are a source of unwanted calories. Many contain potentially harmful vitamins and nutrients that are not be recommended by medical doctors, such as iodine, iron, chromium picolinate, etc. These drinks typically contain significant protein, which may be harmful to anyone who has some kidney insufficiency. (This is especially so, if they are getting other sources of protein in their diet e.g., from meat and dairy products). People have even gained weight on these drinks. Commonly the drink is not fully-satiating, so the individual may eat a meal or snack food in addition to the drink, thereby actually increasing their normal caloric consumption.
Some of the products used as meal replacements can cause drastic weight loss. This is unhealthy as it removes muscle in addition to fat. This drastic weight loss can cause many medical problems, including syncope, fatigue, hypotension, gallstones, dehydration, constipation, blood electrolyte imbalances, heart irregularities, and even death. Some of the more professional products require a physical exam prior to initiating the program and continuous health evaluations while on the weight loss program. Continuous doctor and laboratory monitoring can be both inconvenient and expensive.
The end result of these weight-loss drinks is that they generally do not taste well, are not satiating, contain potentially harmful ingredients, are difficult to stay on long term, and ultimately result in rather minor unsustained weight loss. It is well known that 80% of people who diet regain the weight within a short period of time. Most of these people will continue to gain weight during their lifetime.
There is no good weight-loss method that works for the majority of the population, despite the fact there is such a variety of dietary programs and aids. For the same reason, most dieters have tried several different methods of dieting. Even though some dieters have had some success, they frequently hit a plateau and cannot lose more weight. Eventually, they abandon the weight-loss product and go back to eating as they have always done. Dieters may experience an initial weight loss and then typically regain even more weight than they lost. This common phenomenon, known as yo-yo dieting, is unhealthy and harmful. Recent studies suggest that yo-yo dieting may be more harmful than remaining consistently overweight.
Regarding the low fiber content of the drinks, fiber is the indigestible complex carbohydrates found in plants. It has no calories as the body does not have a way to absorb it. Based on their physical characteristics, fibers can be divided into two groups, water-soluble and water insoluble. Soluble fibers include gum, pectin, various fruits, vegetables, seeds, barley, rye, oat bran, dried beans, and psyllium seed. Insoluble fibers include certain fruits and vegetables, rice, whole grains, cereals and pasta, cellulose, hemicelluloses, lingnins, and psyllium husk. Many fruits and vegetables contain both soluble and insoluble fiber.
Medical and nutritional studies show that fiber is essential to good health. Research shows that it can help prevent cardiovascular disease, diabetes, obesity, gastrointestinal diseases, hypertension, osteoporosis, and several types of cancer. Insoluble fiber has been shown to provide good health to the gastrointestinal tract by providing numerous benefits, including preventing overeating by its absorption of water and slowing gastric emptying. Fiber stretches the stomach, which sends nerve impulses to the brain's satiety center. Insoluble fiber also modifies fat absorption, increases bile acid secretion, absorbs cholesterol and reduces endogenous cholesterol production, and promotes peristalsis to decreases transit time of waste out of the body.
Fiber has been shown to have another important benefit. It detoxifies and speeds the removal of toxic substances. Fiber offers these benefits through several mechanisms. The fibers prevent absorption of some toxins and carcinogens by binding to them in the stomach and small intestine and then speeding them trough the gastrointestinal tract until they are excreted. Bile acids, cholesterol, and toxic heavy metals all stick to the fibers and are excreted in the same fashion.
Other advantages of fiber include a delay in stomach emptying, while stimulating motility of the large intestine. This creates satiety, yet speeds waste products and toxins out of the body. Fiber increases the bulk of the stool and absorbs water, helping to soften the stool and ease evacuation.
The average intake of dietary fiber in the United States is between 10-15 grams per day. Medical researchers and regulatory agencies recommend between 25-40 grams of fiber per day. Increasing the consumption of complex carbohydrates in the form of fiber is thus practically a necessity. Recommendations even run higher for larger people. Current recommendations call for an increase in fruits and vegetables, as well as whole grain breads and cereals to make up this deficit. To obtain an increase of 10-30 grams of fiber a day means eating a lot more of these food items, which could be inconvenient, costly, and could provide a significant source of sugar, fats, calories, and undesirable ingredients to the diet as well.
The US Food and labeling laws allow a manufacturer to call their product “high” fiber if the product contains 20% or more of the recommended Daily Value (DV). In the case of fiber, a product containing as little as 4 grams of fiber per serving can legally be called “high fiber”. The same laws allow a manufacturer to state a product is a “good source” of fiber if it contains 10-19% of the recommended daily value. These terms only serve to confuse the consumer and mislead many to think they are replacing their fiber deficit by having one serving of a product that has a “good source or high fiber” designation.
Beverage products are a convenient way to deliver this fiber. The problem with creating a high-fiber beverage is the fiber itself. Fiber, by its very nature, does not dissolve or mix well in liquids. Fiber tends to clump and form lumps in fluid, or in the case of gums, quickly forms a thick viscous liquid or gel. This increase in viscosity and gelling takes place immediately and is directly proportional to the concentration and/or number of fibers added. In addition to these problems, fiber does not feel good to the tongue and mouth and frequently has a bitter or terrible taste. These organoleptic and unpalatable properties of fiber have made it difficult for people to increase their fiber consumption through the form of a beverage.
Numerous weight-loss beverages exist. Some contain fiber; others do not. The drinks that do contain fiber contain less than 7 grams of fiber per serving, and are not fully-satiating. To address this problem manufacturers attempt to promote satiety through the addition of carbohydrates, fats, and protein to the drink. As a result, these beverages become a source of additional calories and potentially dangerous sugars and fats. Sugars and fats are considered unhealthy to add to the diet as they are damaging to the vascular inner lining and they lead to heart disease, diabetes, obesity, and a variety of health conditions. Manufacturers have not figured out how to make a weight-loss beverage that is rich enough in fiber to be fully-satiating and at the same time palatable. Instead they rely on promoting satiety from the other caloric-rich ingredients or the combination of ingredients rather than the fiber alone. Some of these products, while technically meeting US Food and Labeling requirements to be called a “good source of fiber” or “high in fiber”, actually contain rather meager amounts of fiber. These beverages do not even replace most individuals' fiber deficit when taken at the prescribed daily dose. The required frequent dosing of these products creates both compliance and convenience issues since most individuals have trouble adhering to the prescribed number of doses per day. This results in ineffective weight loss and frequently does not meet the governmental and medical recommendations of 25-40 grams of fiber per day.
These products also seek to create satiety through the addition of protein (whey, non-fat milk solids, casein, etc.) or the addition of fats or other caloric ingredients. One product sold under the trademark ULTRA SLIM•FAST is arguably the best selling and highest fiber over-the-counter weight-loss beverage. It comes in a variety of flavors and contains 10 grams of protein, 35+ grams of sugar, 2.5-3 grams of fat, and 5 mgs of cholesterol, in addition to the 5 grams of fiber per 325 cc serving. Of the total carbohydrate listed on the nutrition facts label, the weight of its sugars exceed the weight of its fiber grams by a ratio of 7 to 1.
The manufacturer of the SLIM•FAST beverage has a website which recommends a “SLIM•FAST PLAN” which consists “of 2 shakes or 2 MEAL-ON-THE-GO-BARS® a day, along with a sensible meal, as well as snacks.” SLIM•FAST powders contain only 2 grams of fiber per serving. (The ULTRA SLIM FAST powders discussed above and ULTRA SLIM•FAST READY-TO-DRINK SHAKES contain more fiber—5 grams of fiber per serving, but this is still insufficient to replace most individuals' fiber deficit and would not cause satiety without the added fat and protein found in the drink). The SLIM•FAST powders that are not premixed are supposed to be mixed with 8 fluid ounces of fat-free milk. Consuming two ULTRA SLIM•FAST beverages as directed, provides a total of only 10 grams of fiber per day. Two of their snack bars or SLIM•FAST SHAKES provides only 4 grams of fiber per day. Thus individuals following this plan can still remain deficient in fiber. The SLIM•FAST snack bars come in a variety of flavors and in general contain 5 grams of fat, 23 grams of sugar, 8 grams of protein yet only 2 grams of fiber. The carbohydrates listed are in a ratio of 9 to 1, sugar to fiber.
HERBALIFE, located in Century City, Calif., is a successful network marketing company that has been in business over twenty years. They sell a high protein, low-carbohydrate program weight-management drink mix under the trademark HERBALIFE THERMOJETICS which comes in various flavors and contains 70-80 calories, 0.5 gram of fat, 15 grams of protein, and no fiber whatsoever. The HERBALIFE THERMOJETICS drink shake mix comes in chocolate and vanilla and contains 110 calories, 3-4 grams of fat, 15 grams of protein, and only 1 gram of dietary fiber. The nutrition facts panel listed on the HERBALIFE website does not list the recommended number of daily servings, but assuming even three shakes per day, the total fiber consumed would be only 3 grams.
Various products exist for both weight loss or bowel irregularity containing much less than 4 grams of fiber per serving. OPTIFAST, a trademark of (Novartis, Minneapolis, Minn.), is a doctor-supervised program in which individuals can consume either a powder mix, a ready to drink formula, or a soup under the OPTIFAST 800 trademark—all containing no fiber. MEDIFAST, a trademark of (Jason Pharmaceuticals, Inc. Baltimore, Md.), is another doctor-supervised weight loss program. The MEDIFAST drink contains only 3 grams of fiber per serving. METAMUCIL drink (Procter & Gamble) also contains 3 grams of fiber per serving. CITRUCEL drink (Merrell Dow Pharmaceuticals Inc.) contains 2 grams of fiber per serving. FIBERCON (calcium Polycarbophil) pills (Wyeth, Madison, N.J.) contains only 1 gram of fiber per serving. BIOSLIFE2 drink (Unicity Network Orem, Utah) is a product advertised for weight management and for cholesterol lowering. It still contains only 4.5 grams of fiber per serving. Most of these products are taken once to three times daily. In many cases these “high” fiber products do not approach the 10-25 gram fiber deficit most Americans suffer. Consequently, users of these products do not obtain all the health advantages of higher fiber in the diet.
One reason most manufactures limit the fiber to 3 grams or less is the problem with gastrointestinal side effects. Typically the more the fiber consumed, the greater the chance that the fiber will cause bloating, abdominal pain, and diarrhea.
Manufacturers also have not produced a beverage containing 7 or more grams of fiber due to the problems in viscosity, clumping, and gelling. To get even 3 grams of fiber, manufacturers use low-viscosity fibers, or guar that has been hydrolyzed to decrease viscosity. Other ingredients (sugars, fats, proteins) are added then to assist in making the drink organoleptically pleasing.
Various prior-art publications have discussed a need to get around the obstacle of making a high fiber beverage that is organoleptically acceptable and drinkable by complicated processing. Kota, in U.S. Pat. No. 5,976,603, Nov. 2, 1999, describes how fiber can be combined with a carrier and flash-flowed processed into a shearfrom matrix to prevent clumping. Barbera, in U.S. Pat. No. 5,219,570, Jun. 15, 1993, teaches how psyllium husk can have improved mixablity and dispersability by dispersing an edible acid in an agglomerating coating. Wang, in U.S. Pat. No. 6,004,610, Dec. 21, 1999, teaches that hydrolyzed guar gum mixed with arabinogalactan creates a low-viscosity product that is suitable for drinking. Beher, in U.S. Pat. No. 5,545,414, Aug. 13, 1996, teaches that a nutritional bar with fiber (guar) encapsulated with zein gives improved mouth feel.
These prior-art approaches have significant limitations, complications, and expenses to the manufacturing of the product, yet still do provide less than 7 grams of fiber per serving.